Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Study information

Scientific title

A proof-of-concept study to evaluate the benefit from add-on therapy with montelukast versus salmeterol in children with asthma carrying the Arg/Arg-16 beta2-receptor genotype

Acronym

Study hypothesis

The purpose of this study is to determine whether patients with asthma who carry a genotype associated with adverse outcomes with long-acting beta-2 agonists like salmeterol show greater benefit from the use of an asthma drug that works via alternative pathways like montelukast.

Ethics approval

Ethics approval received from Tayside Committee on Medical Research Ethics on the 2nd November 2006 (ref: 06/S1401/86).

Study design

Interventional, single-centre, randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details provided in the interventions field to request a patient information sheet

Intervention type

Phase

Drug names

Primary outcome measure

Oral montelukast is associated with reduced school absences in comparison to inhaled salmeterol over a period of 1 year in Arg/Arg-16 asthmatic children.

Secondary outcome measures

1. Oral montelukast is associated with reduced out-of hours visits/hospital visits or admissions in comparison to inhaled salmeterol over a period of 1 year 2. Oral montelukast is associated with a reduction in airway resistance in comparison to inhaled salmeterol over a period of 1 year 3. Oral montelukast is associated with reduced exhaled nitric oxide levels in comparison to inhaled salmeterol over a period of 1 year 4. Oral montelukast is associated with reduced salivary eosinophilic cationic protein levels in comparison to inhaled salmeterol over a period of 1 year 5. Oral montelukast is associated with improved asthma specific quality-of-life in comparison to inhaled salmeterol over a period of 1 year 6. Oral montelukast is associated with improved morning peak expiratory flow rate in comparison to inhaled salmeterol over a period of 1 year

Overall trial start date

01/08/2007

Overall trial end date

31/12/2009

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

All children and adolescents (5 - 18 years, either sex) with asthma in Tayside (Scotland) known:1. To carry the Arg/Arg-16 genotype, and2. Currently on inhaled steroids, and 3. Inhaled bronchodilators according to need Will be telephoned or contacted through home visits to establish if they have had:1. Any school absences from asthma, or 2. Out-of-hours visits to General Practitioner (GP)/hospital visits or admissions due to asthma over the previous 12 months

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

120

Participant exclusion criteria

The presence of serious respiratory or multi-system disease (e.g. cystic fibrosis, cancer under current treatment)